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The PLEGIOX Heat Exchanger is used to set and maintain the temperature (for given flow rates and within the given temperature range) of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation.

The product is designed for single use only, for an application period of no longer than 6 hours.

The PLEGIOX is a cardioplegia heat exchanger with integrated bubble trap. It is delivered in a pyrogen-free and sterile status.

The provided text is related to a 510(k) submission for a medical device called the "PLEGIOX Cardioplegia Heat Exchanger with Softline Coating." This document generally outlines the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not contain the detailed information required to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, method of operation, components, packaging, fundamental scientific technology, and performance, integrity, biocompatibility, and sterility testing. It states that "Evaluation on safety and effectiveness was executed to demonstrate that the PLEGIOX Cardioplegia Heat Exchanger with Softline Coating described in this submission is substantially equivalent..." but it does not provide the details of these evaluations in terms of specific acceptance criteria, test results against those criteria, or the methodology of the study.

Therefore, I cannot provide the requested information based on the provided text. To answer your questions, I would need a different document, such as a detailed study report or a more comprehensive technical file that describes the specific performance validation testing performed for the device.

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